Decubitus Ulcers And Mepilex Essay

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Decubitus Ulcers And Mepilex Essay

1. The decubitus ulcer : also known as pressure ulcer or bed sore refers to an open wound found on the surface of the skin. Decubitus ulcer is often found on the skin that covers bony areas especially on the hips and at the back (Walsh et al., 148). Mepilex : is a dressing form that is used to dress various wounds.

Definitions

Above are the definitions of Decubitus Ulcers and Mepilex dressing as a method of treating and controlling the disease.

2. Advantages of Mepilex Minimizes pain when dressing changes

Effectively exudate management Reduces the risk of macerationIt is soft and Conformable

Above are the various advantages of Mepilex

Myths and Truths of Dressing Decubitus Ulcers (DU)

Myth 1: Dressing meant for open used is not suitable for DU preventionTruth: A variety of dressings including foams, hydrocolloids and films can be prevent DU

Myth 2: When Dressing is used, no other DU preventive method can be usedTruth: Standard DU prevention measures can be continued even after dressing has been used (Carter et al., 25) Decubitus Ulcers And Mepilex Essay.

Myth 3: Dressings are so thin such that they cannot prevent the causative agents of DU

Truth: Dressings can reduce friction, redistribute shear and prevent over-hydrationAbove are various myths about using dressing to treat and control Decubitus Ulcers

Myth 4: A dressing should be left undisturbed until the next time for change

Truth: A dressing can be used for several days though a physician inspects the dressing from time to time.

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Myths continued

Goals of the Project

Set up a health facility with all the necessary healthcare providers and tools to prevent and treat Decubitus ulcer with the use of Mepilex dressing

Risk Assessment: The healthcare team will be educated on how to use each tool and the basics in Decubitus ulcers related issues

Skin Assessment: Before Mepilex dressing is carried out, the skin of the patients will be assessed to determine skin moisture content, the condition of the skin and extent of damage. Practical precaution measures will be initiated whenever needed.

Nutritional support: The facility will have a nutritionist who will advise the patients on the recommended foods and also check the hydration status of the patients

Repositioning: Healthcare providers will ensure that repositioning will be carried out in a manner that prevents shear or friction forces. A 30-degree tilted side lying position will be used.

Support surfaces: Patients will be engaged so as to determine the most suitable devices to be used.Decubitus Ulcers And Mepilex Essay. For example, the patient may require a certain positioning of the pillows.

Specialist Groups: The facility will link the patients with various specialised groups where the patients can get various supports. Above are the various goals set for the project.

The effectiveness of the facility in terms of cost, time and resources

The number of patients over time

How effective the method is in curing the diseaseWhether the patients are contented with the services offeredHow successful the disease was cured without re-emerging after some time.

How to Determine if the goals are Achieved

Above are the various ways we shall determine if our goals are achieved or not.

Infrastructure and Interior Design Cost Program Expenses Budget Amount Rental Fees $600,000 Processing of Legal Documents $150,000 Furnishes of all buildings $300,000 Interior Design to Suite the Legal Requirements $150,000 Security Features $85,000 Lighting, Sewage and Water Connection Expenses $300,000 Total ? $1,585,000

The various expenses that will be spent in infrastructure and interior design of the facility8 Description Cost Mepilex Border $ 12,000 Gloves $120 Cotton wool $50 Trolley $600 Cleaning Detergents $200 Water distiller $2400 Examination lamp $3000 Diagnostic set $5,000 Stethoscope $4,000 Drug cabinet $307,000 Thermometer $200 Weighing scale adult $240 Screen bed $1200 Total $336,010

Costs for Tools and Equipment

Above are the estimated costs for various tools and equipment that the facility will require9Cost on Staff Position Annual Salary Total Clinical Superintendent 85,000 85,000 Clinical Supervisor 73,400 220,220 Medical Physician 187,200 (3) 371,600 Physician Assistant 98,200 294,600 Pharmacist 121,500 243,000 Chief Financial Officer 95,000 95,000 Sales Representative 102,200 102,200 Administrative Assistant 40,600 40,600 Human Resource Manager 63,700 63,700 Security Guards 28,400 (4) 113,600 Record Keeper 34,600(2) 69,200 Total $1,698,720The estimated annual cost on staff is as shown above. Decubitus Ulcers And Mepilex Essay.

Task Timeline

Agreements and contracts 3 months Place orders for equipment 3 months Determine opening date 3 months File necessary regulatory forms and documents 3 months NM/BMT start working on the new facility 2 months Finalize number of workers and staff needed/ hire the staff 2 months.

The timetable of events before the operations start11 Task Timeline Order signage 2 months Setup medicine accounts 2 months Establish continuous quality improvement(CQI) 2 months Order long distance services 6 weeks Coordinate installation of equipment 6 weeks Verify installation of equipment/furniture 6 weeks Count inventory and place reorder 6 weeks.

Task Timeline Inform patients transferring from other facilities 1 month Purchase office supplies 1 month Negotiate line/laundry service 1 month Purchase housekeeping supplies 2 weeks Setup emergency services 2 weeks Schedule patients on the dressing rooms 1 week Work on patient/staff schedules 1 week.

Data Collection Mechanisms

Questionnaires: Open and closed questionnaires will be distributed to patients and healthcare professionals who treat decubitus ulcerResearch: Government records, internet sources and credible medical documents will be reviewed

Interviews: Various Health care providers and leaders will be interviewed and their ideas recorded.

The various data collection mechanisms in the project are shown above.

Change and leadership theories to ensure success

Model of Change (Kotter)

Creating a climate for Change

Create the need for an urgent changeBuild a coalition Form strategic initiatives and visionThe most suitable model of change is shown above which is the Kotter model.

Engaging and enabling

Communicate the vision to people

Remove barriers to enable actionIdentiy short-term winsImplementing and sustaining

Sustain the winsInstitute change (Kuo et al., 3204 ) Decubitus Ulcers And Mepilex Essay.

Kotter model continued

ConclusionThe above slides describe the planning and implementation stages of the project of treatment and prevention of decubitus ulcer by the use of Mepilex dressing.

The goals of the project have been identified and described. Also, the resources that are required for the project have been identified and considered the change management measures. A detailed project plan has been outlined. The plan’s resources have been outlined and the time schedule for various activities identified. The most suitable change and leadership theory for the project has also been described. Conclusion of the project highlighting various aspects of the project.

Mepilex Border Sacrum and Heel dressings are self-adherent, multilayer foam dressings designed for use on the heel and sacrum aiming to prevent pressure ulcers. The dressings are used in addition to standard care protocols for pressure ulcer prevention. The National Institute for Health and Care Excellence (NICE) selected Mepilex Border Sacrum and Heel dressings for evaluation. The External Assessment Centre (EAC) critiqued the company’s submission. Thirteen studies (four randomised controlled trials and nine nonrandomised comparative studies) were included. The majority of studies compared Mepilex Border Sacrum dressings (plus standard care) with standard care alone. Comparative evidence for Mepilex Border Heel dressings was limited. A meta-analysis indicated a non-statistically significant difference in favour of Mepilex Border Sacrum dressings for pressure ulcer incidence [RR 0.51 (95% CI 0.22–1.18)]. The company produced a de novo cost model, which was critiqued by the EAC. Decubitus Ulcers And Mepilex Essay. After the EAC updated input parameters, cost savings of £19 per patient compared with standard care alone for pressure ulcer prevention were estimated with Mepilex Border dressings predicted to be cost saving in 57% of iterations. The Medical Technologies Advisory Committee reviewed the evidence and judged that, although Mepilex Border Heel and Sacrum dressings have potential to prevent pressure ulcers in people who are considered to be at risk in acute care settings, further evidence is required to address uncertainties around the claimed benefits of the dressings and the incidence of pressure ulcers in an NHS acute-care setting. After a public consultation, NICE published this as Medical Technology Guidance 40.

Key Points for Decision Makers

Mepilex Border Heel and Sacrum dressings show promise for preventing pressure ulcers in people who are considered to be at risk in acute-care settings. However, there is currently insufficient evidence to support the case for routine adoption in the NHS.

Research is recommended to address uncertainties about the claimed benefits of using Mepilex Border Heel and Sacrum dressings. This research should also explore issues such as:

the incidence of heel and sacrum pressure ulcers in NHS acute-care settings

criteria for patient selection to reduce pressure ulcer incidence with Mepilex Bord er Heel and Sacrum dressings in addition to standard care. Decubitus Ulcers And Mepilex Essay.

The National Institute for Health and Care Excellence (NICE) evaluates medical technologies and, where appropriate, produces evidence-based guidance to encourage adoption of novel and innovative medical devices and diagnostics within the National Health Service (NHS) in England. NICE’s Medical Technologies Evaluation Programme (MTEP) receives notifications of medical technologies, most commonly from product manufacturers, which are selected for evaluation based on criteria, including whether they have the potential to offer clinical benefits to patients and/or reduce costs compared with standard care.

A scope is produced by NICE detailing the decision problem to be addressed, and clinical and economic evidence submitted by the company is assessed independently by an External Assessment Centre (EAC). Following the EAC’s evaluation and public consultation period, the Medical Technologies Advisory Committee (MTAC) develops guidance. The methodology adopted by the MTEP is described in more detail in its methods and process guides [1, 2].

In January 2019, NICE issued final guidance on Mepilex Border Sacrum and Heel dressings for use with patients at risk or at high risk of pressure ulcers. Mepilex Border Sacrum and Heel dressings are self-adherent, five-layer foam dressings specifically for use on the heel and sacrum. The dressings have been designed to reduce friction between the skin and the dressing, prevent stretch or tear of the skin and absorb moisture, with the aim of preventing the occurrence of pressure ulcers. The EAC critiquing the evidence was the Newcastle upon Tyne NHS Foundation Trust and York Health Economics Consortium partnership. Clinical experts, identified using NICE’s published processes, provided advice to the EAC and MTAC.

This article includes an overview of the clinical and cost-effectiveness evidence submitted by the company, the EAC’s report and the subsequent development of the NICE guidance. Full documentation of the process, final guidance and supporting evidence is available on the NICE website [3]. Decubitus Ulcers And Mepilex Essay.

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Background to the Indication and Devices

Pressure ulcers are localised injuries to the skin and/or underlying tissue as a result of pressure, or pressure in combination with shear [4]. Pressure ulcers can range in severity and can be classified into the following categories or stages [5]:

Stage 1 Intact skin with non-blanchable erythema of a localised area. Discoloration of the skin, warmth, oedema, hardness or pain may also be present.
Stage 2 Partial thickness loss of dermis presenting as a shallow open ulcer with a red/pink wound bed, without slough or bruising. It may also present as an intact or open/ruptured serum-filled blister.
Stage 3 Full thickness tissue loss. Subcutaneous fat may be visible, but bone, tendon or muscle are not exposed. Some slough may be present. It may include undermining and tunnelling.
Stage 4 Full thickness tissue loss with exposed bone, tendon or muscle. Slough or eschar may be present. It often includes undermining and tunnelling.

Pressure ulcers can have a significant impact on a patient’s quality of life, both physically and psychologically. They can also lead to further health complications such as infection, extended hospital stays, restricted rehabilitation and restricted treatment options for other medical conditions [6, 7].

All patients are at risk of pressure ulcers. Decubitus Ulcers And Mepilex Essay. However, Mepilex Border dressings have been indicated for use in people identified as either ‘at risk’ or ‘at high risk’ of developing a pressure ulcer.

Guy [8] reports that risk factors for pressure ulcers include:

Reduced mobility or immobility—pain is a warning signal that pressure has been exerted for too long, which normally triggers movement. Patients who are unable to move will require the help of someone else in order to do so.
Lack of sensation—if pain signals are absent, patients may not be aware that damage is occurring and will not realise that they should move. This includes anything which may impair sensation including unconsciousness, analgesia or alcohol/substance abuse.
Nutritional status—it is widely accepted that undernourished people are at increased risk of pressure ulcer development.
Compromised vascular supply—skin with compromised vascular supply may deteriorate more rapidly. Patients with peripheral arterial disease, or patients who experience events such as cardiac arrest or hypovolaemic shock may be at increased risk.
Moisture—skin that is constantly or often moist is at increased risk of pressure ulcer.
Friction and shear—these forces are additional to pressure, and further hamper blood flow by stretching and contorting blood vessels. This is most commonly seen in the sacrum and heels.

In addition to the risk factors described above, clinical experts also indicated that the following conditions may also increase the risk of developing a pressure ulcer: diabetes, dementia, significant cognitive impairment, tremors, leg spasms, leg oedema, critical illness, low or high body mass index (BMI), terminal illness, extremes of age, previous history of pressure damage and long theatre times.

Risk assessment tools such as the Braden scale, the Waterlow score and the Norton risk-assessment scale are recommended by NICE to be used alongside clinical judgement to determine whether a person is at increased risk of developing a pressure ulcer [9]. Decubitus Ulcers And Mepilex Essay.

In addition to risk assessment for all people admitted to secondary care, standard care protocols for prevention of pressure ulcers recommended by NICE [9] include:

Skin assessment either once daily or more often for those assessed as being at high risk of a pressure ulcer, and less frequently for those at lower risk.
Repositioning at least every 6 h for people at risk, or every 4 h for people at high risk of developing a pressure ulcer.
Use of specialist equipment such as high-specification foam mattresses/cushions and/or devices to offload heel pressure.
Use of barrier creams in people at high risk of developing a moisture lesion or incontinence-associated dermatitis, as identified by skin assessment.

Mepilex Border dressings are intended for use in addition to standard care protocols for pressure ulcer prevention.

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Decision Problem (Scope)

Population

The population described in the scope included patients at risk or at high risk of pressure ulcers in an acute care setting as defined using a validated assessment scale. The company also included evidence on patients in an aged-care setting; however, this was subsequently excluded by the EAC in line with the scope. The majority of evidence identified by both the company and the EAC was in high-risk patients.

Intervention

Interventions identified in the scope were Mepilex Border Heel dressings and Mepilex Border Sacrum dressings used as an adjunct to standard NHS clinical practice. The company (Mölnlycke Health Care) included evidence on Mepilex Border general dressings (not specific to heel or sacrum) and Mepilex dressings (a 3-layer version of the Mepilex Border dressing). The EAC included evidence on Mepilex Border general dressings (when applied to the heel or sacrum) but excluded evidence on the Mepilex three-layer dressings as these were deemed to be out of scope given that they are a separate device utilising different technology. Decubitus Ulcers And Mepilex Essay.

Comparator

The comparator listed in the scope was standard NHS clinical practice for patients considered ‘at risk’ or ‘at high risk’ of pressure ulcers, which may involve a combination of:

Risk assessment with a validated scale.
Skin assessment.
Frequent repositioning.
Pressure redistribution devices such as high-specification foam mattresses.
Other dressings or skin applications.
Information.
Barrier cream.

Evidence submitted by the company included studies conducted in countries outside of the UK and, therefore, standard care varied across studies and was not always consistent with the scope. Neither the company nor the EAC identified any comparative UK evidence.

Outcomes

The company’s submission addressed five of the ten outcomes identified in the scope. Specifically, evidence was provided for the incidence of pressure ulcers, stage of pressure ulcers, level of patient satisfaction, level of pain and discomfort and impact on quality of life, and ease of use of product. No evidence was identified by either the company or the EAC on the following outcomes specified in the scope: incidence of skin breakdown at the heel and sacrum, additional length of hospital stay as a result of pressure ulcers, patient compliance with pressure ulcer prevention strategies, complications avoided from pressure ulcer prevention strategies and device-related adverse events. Decubitus Ulcers And Mepilex Essay.

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Review of Clinical and Economic Evidence

Section 4.1 summarises the clinical evidence submitted, the EAC’s critique of the clinical evidence and the EAC’s additional work. Section 4.2 provides the same detail for the economic evidence.

Clinical Effectiveness Evidence

Company’s Review of Clinical Effectiveness Evidence

The company identified 203 records through its literature search and included 34 studies reported across 35 records, comprising:

Five randomised controlled trials (RCTs), including four [10–13] published and one unpublished. Since the company submitted its report, a full publication became available for the unpublished trial [14].
Twenty-two observational studies, including 14 published [15–28] and 8 unpublished [29–36].
Seven published systematic reviews [37–40]. Decubitus Ulcers And Mepilex Essay.

The company completed the relevant results and methodology tables for each included study and attempted to critically appraise the evidence. The company did not synthesise the outcomes using a meta-analysis. Instead, a narrative synthesis of study results was provided, and the company commented on the synthesis conducted in several published systematic reviews.

Critique of Clinical Effectiveness Evidence

The EAC identified several limitations to the company’s search methodology, and their selection criteria were not in full alignment with the NICE scope. The EAC re-ran the company’s literature search as far as possible, conducted a de novo search and realigned the selection criteria with the scope to identify relevant clinical evidence on Mepilex Border Heel, Mepilex Border Sacrum and Mepilex Border (when applied to the heel or sacrum) dressings. Full details of the EAC’s search strategies are described in the assessment report [41]. The EAC identified 1242 records, which were assessed by 2 reviewers (see Fig. 1).

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Fig. 1

EAC’s PRISMA diagram. EAC external assessment centre

Due to the sufficient volume of comparative evidence identified, the EAC limited eligible study designs to RCTs and non-randomised comparative studies. Single-arm studies were considered for adverse events only. Thirteen studies reported across 23 records were eligible for inclusion in the review. The reviewed evidence comprised:

Four RCTs. Three of which were identified and included by the company [10, 11, 13] and one newly identified by the EAC [42].
Nine comparative observational studies [17–19, 23–25, 28, 33, 36]. All of these studies were identified and included by the company.

All of the studies included by the company were successfully identified by the EAC. However, 22 studies (2 RCTs [12, 14, 25], 2 non-randomised comparative observational studies [21, 22], 12 single-arm studies [15, 16, 20, 26, 27, 29–32, 34, 35, 43] and 7 systematic reviews [37–40, 44–46]) were subsequently excluded based on the EAC’s updated eligibility criteria. Detailed reasons for excluding these studies and detailed information on the studies included by the EAC are reported in the EAC’s assessment report [41]. Decubitus Ulcers And Mepilex Essay.

The four included RCTs were published as full papers and compared Mepilex Border Sacrum plus standard care with standard care alone [10, 11, 13, 42]. Standard care varied across the RCTs, but specific components that aligned with the scope included pressure redistribution [10, 11, 13, 42], regular repositioning and skin care [10, 11], skin assessment [42] and risk assessment by Braden score [13]. The populations in all four RCTs were well matched with the scope of the decision problem, recruiting adult patients at high risk of pressure ulcers in acute care settings. All four trials were conducted outside of the UK.

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Seven of the nine non-randomised comparative studies compared Mepilex Border Sacrum [17–19, 24], Mepilex Border Heel [13, 33] or Mepilex Border [23] dressings plus standard care with standard care alone. One study compared Mepilex Border with a hydrocolloid dressing, both in conjunction with standard care [36]. One study conducted a bilateral comparison of Mepilex Border and a polyurethane film dressing applied to the chest and heel [28]. There was a wide variation in standard care across the studies, with the majority utilising a mixture of components aligned with the scope. The studies were generally well matched with the scope in terms of their populations and recruitment, recruiting patients at risk or high risk of pressure ulcers in acute care settings. All nine studies were conducted outside the UK.

The EAC judged that all of the RCTs provided an acceptable level of internal and external validity with the exception of one trial [11], which had high internal validity and acceptable external validity. Only three observational studies [23–25] had an acceptable rating for both internal and external validity.

The studies reported few outcomes of interest that were specified in the scope. The most commonly reported outcomes were the incidence rate and severity of pressure ulcers as assessed using established guidelines [4, 5].Decubitus Ulcers And Mepilex Essay. The EAC synthesised the results from three RCTs comparing Mepilex Border Sacrum to standard care using a fixed-effect meta-analysis in relation to the number of patients developing pressure ulcers. The pooled estimate showed a non-statistically significant difference [RR = 0.51 (95% CI 0.22–1.18), p = 0.12] in favour of Mepilex Border Sacrum (see Fig. 2). Results from one study assessing Mepilex Border Heel and one study assessing Mepilex Border showed a statistically significant difference in favour of the intervention (p ≤ 0.001) for pressure ulcer incidence. Where results relating to the stage of pressure ulcers were reported, higher stage pressure ulcers typically developed in patients not receiving the intervention. Decubitus Ulcers And Mepilex Essay.